Surgical and laboratory procedures are fraught with the possibility of infectious contact of surgical and laboratory personnel with body fluids, particularly the blood of patients and of test specimens. Surgical gowns and gloves are designed to provide protection. However, exigencies of the situation, particularly with the use of sharp instruments, contact with bone, application of excessive pressure and necessarily thin gloves can occasionally lead to unnoticed pinholes, rips, etc. in the protective garment. This leads to the ingress of possibly infectious body fluids into direct contact with the surgical personnel. The prevalence of AIDS and HIV has most recently exacerbated such concern. Accordingly, devices have been utilized during surgery to warn surgical personal of breakages and breaches in protective garments worn during surgery, in order to minimize the extent of exposure to contaminated fluids and the transmission of bacteria or viral pathogens. Expedients to alleviate such concern generally encompass the use of pin-hole detection devices which provide immediate warning of even small breaches to allow for immediate effective action.
An example of such warning device is disclosed in U.S. Pat. No. 4,956,635 in which a circuit, interrupted by the surgical gloves, is established between surgeon and patient. A reference external electrical circuit is established on the surgeon, wherein a breach in the glove barrier results in a measurable voltage drop which triggers an alarm warning. However, spurious signals can be triggered, such as by static electric charge build-ups and discharges, which generate a sufficient voltage. Interruptions in surgical procedures resulting from spurious signals are costly and possibly harmful.
In my prior U.S. Pat. No. 5,430,434, the disclosure of which is incorporated herein, by reference thereto, an alarm device was described for use in detection of a breach in at least one protective barrier between an object and at least one carrier, during surgical and health care procedures but with contained means for minimizing spurious alarms. The device is separately electrically connected, with individual connections to the object and at least one carrier, said device comprising alarm means, central processing means, and means to constantly monitor integrity of each connection during use of the device. Any failed connection condition causes the alarm means to generate an alarm as to such condition to enable the failed connection condition to be corrected. With a breach in the protective barrier, and establishment of a conductive connection between the object and one carrier, a circuit is completed through the device with a current generation, and a warning alarm is triggered by the alarm means. The device further having discrimination means wherein said alarm is only triggered when the discrimination means determines that the generated current is of a specific predetermined type.
The device described in said patent is portable or use in detection of breaches in protective garments such as gloves, during surgical procedures and the like. The device is electrically connected to an object (e.g. patient) and one or more carriers (e.g. a surgeon and/or health care workers) and comprises electrical pulse generation means and central processing means whereby electrical pulses, continually generated by the electrical pulse generation means, are separately directed to the surgeon and the patient, to monitor integrity of each connection during use of the device. A failed connection provides an alarm as to such condition to enable it to be corrected. With a barrier breakdown, such as a hole in a surgical glove, and establishment of a conductive fluid connection with in vivo patient fluids, such as blood (of a possibly hazardous nature), a circuit is completed between the surgeon and patient, and through the device, and a warning alarm is triggered. Such alarm is however only triggered when the central processing means determines that a generated current is of a pulse type and is of the specific pulse rate generated by the pulse generation means. The pulse generations for each of patient and surgeon are preferably identical but phase shifted so that they are separately identifiable. With the completion of the circuit between surgeon and patient, the pulses are shunted to the breach alarm circuit and combined. It is this combined pulse rate which is detected and analyzed by the central processing means.
The pulse generation and rate detection eliminates any spurious signals with unwanted alarm triggering. The device senses only the presence or absence of the pre-established signal and is analogous to a switch being open and closed. Secondary source changes in resistance levels, as is possible with prior art devices, are not a factor in alarm triggering. Such alarm may be in the form of visual, audio or tactile indications, e.g. a blinking warning light, a sounding buzzer or beep, or a detectable vibratory movement. In a preferred embodiment, means are provided for a remote perception of the alarm near the surgeon's eyes or ears. Separate alarm indicators inform the user of low battery condition and loss of connection integrity from either the surgeon or patient connection.
In an embodiment of the device, the device embodies a central processor and source unit containing sensing wave or pulse generator, indicators, driving circuitries, digital analyzing and monitoring circuitries and a power source. The device is separately directly connected to the object, e.g. skin of the patient, and to the device carrier, e.g. skin of the surgeon, via standard two conductor wires and EKG type dual electrodes. The driving and monitoring circuitries, which generates a pulse specific current, prevents spurious signals despite the heightened sensitivity required by the device for triggering and the presence of numerous electronic devices, with emitting electrical discharges, which are present in operating rooms. The device is provided with self diagnostic monitoring means to ensure proper over-all hook-up; separate proper connection to each of the surgeon and patient; sufficient battery power; and proper operation.
In all such prior devices electrical contact is made with the surgeon's (and patients) or other workers' skin by means of disposable adhesively attached leads. These leads require time and effort to adhere, are not safely reusable and because of the adhesive used, are uncomfortable and possibly painful to utilize and remove and may be difficult to be properly located for a good electrical contact.